What are the FDA requirements for food- USA Food regulations

FDA requirements for Food explained
FDA Requirements for Food Products

FDA requirements for food- USA Food regulations  

 

FDA regulates foods and food ingredients sold in the USA, with the exception of meat, poultry, and certain processed egg products regulated by the U.S. Department of Agriculture (USDA).

 

1. Food Facility Registration

Food facility registration is one of the  FDA requirements for food products.

If you are a foreign company or importing food products manufactured in foreign country, then such foreign facilities are required to appoint U.S Agent and register the facility.  Pragmatic Compliance LLC shall act as U.S Agent for food facility registration purpose and register the facility. Our fee for food facility registration including one-year U.S Agent services is $ 299.

You can complete our online food facility registration form below link and make the payment. It will take less than two working days to obtain a food facility registration number. 

If you are domestic food manufacturing, processing, packing or warehouse facility, you are required to register with FDA. Our fee for domestic food facility registration is $ 149. Please contact us for the offline form. 

Please note, FDA does not issue the food facility certificate and the certificate is not required. You will get the food facility registration number from the FDA through email.  Our company can issue the food facility registration certificate for your reference.

2.Labeling Compliance   

Product labeling is one of the  most important FDA requirements for food products.

Labeling is one of the important FDA requirements for food products.  We can offer labeling review services and our fee for per product labeling review is $ 299. In order to review the label, you should provide us label design in PDF or image format. 

We offer discounts on multiple labeling reviews.

Failure to comply with labeling requirements may result in a misbranded product and detention action.

3.Prior Import notice 

Before shipping goods, you must notify FDA about the arrival of your shipments well in advance by submitting prior import notice.

If you wish to file prior import notice yourself, we can send you the step by step instruction which you can follow and submit the prior import notice. If you want us to submit prior import notice, then our fee per shipment prior notice filing is $ 15. 

4.FSVP Agent or Importer

The foreign manufacturer is required to identify the importer for FSMA compliance purposes. If you are an importer or already have an importer in the United  States, such an importer is responsible for supplier verification responsibilities.

Pragmatic compliance can act as an FSVP importer for foreign companies, the fee for  FSVP Agent services depends on the Product and projected annual sales in terms of USD.

The foreign manufacturer has to go through our supplier evaluation process and we may  require several product quality and safety-related documents in order to act as FSVP Agent.  Please contact us for more information.

5.  Good Manufacturing Practice and HACCP

GMP and  HAACP are  most important  FDA requirements for food manufacturers.

In order to food and dietary supplements in the United States companies should follow GMP and maintain proper documentation. After the facility is registered you can start shipping the products however FDA may inspect the food facility for food safety or GMP compliance verification. 

Additional requirements Low Acid or Acidified Products

All commercial processors of low-acid and acidified foods located in the United States and all processors in other countries who export low-acid canned food or acidified food products into the United States must register their processing plants with FDA. Wholesalers, importers, distributors, brokers, etc. are not required to register and file processes. However, they must ensure that processing firms they represent comply with all registration and process filing requirements.

List of important FDA regulations for foods. 

 

Here is the list of some important FDA regulations for foods.   A complete list of FDA regulations for food can be found in the  21 CFR  SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION

 

General  21 CFR Part 100

Food labeling regulations  21 CFR  Part 101 

Foods for special dietary  use  21 CFR  Part 105 

Good manufacturing  practice (GMP) 21 CFR Part 110 

GMP for dietary supplements  21 CFT Part  111

Hazard analysis and critical control points  (HACCP) 21 CFR Part  120 

Dietary  Supplements 21 CFR  Part 190 

 

Note: – If you are low acid or canned food manufacturer please contact us for more information.

 

Translate »